* European Medicines Agency recommends Bexsero
* Decision likely to be formally endorsed in 2-3 months
* Uptake of vaccine hinges on support from governments
By Ben Hirschler
LONDON, Nov 16 The first vaccine against
meningitis B has been recommended for approval in Europe in a
boost for its maker Novartis, which has struggled in
the vaccines field against larger rivals.
The European Medicines Agency (EMA) said on Friday that its
experts had given a green light to Bexsero for the prevention of
"MenB". There is currently no approved vaccine offering broad
protection against this particular type of meningitis.
MenB is caused by bacteria, leading to inflammation of the
lining around the brain and spinal cord. It can kill within 24
hours and infants are at highest risk.
Around 10 percent of those who contract the disease die,
despite appropriate treatment, and up to 20 percent of survivors
suffer from serious disabilities such as brain damage and
Securing European backing for Bexsero for use from two
months of age is a vindication of the Swiss drugmaker's research
in vaccines, where it lags behind market leaders GlaxoSmithKline
, Sanofi and Merck.
The company is pinning high hopes on Bexsero - which is the
result of more than 20 years of vaccine research - and the new
product will complement another meningitis vaccine it already
has on the market called Menveo that covers other strains of the
Recommendations from the EMA are normally endorsed by the
European Commission within a couple of months. That will allow
Novartis to launch Bexsero in 2013 - but its commercial success
still depends on whether individual governments then decide to
add it to routine vaccination programmes.
Novartis said it was committed to making Bexsero available
"as soon as possible" and was already engaging with governments
interested in its early adoption.
Tim Anderson, an industry analyst at Bernstein, believes
getting Bexsero widely adopted may not be easy because although
MenB is a serious disease with high mortality, its incidence is
"If the disease occurs only rarely, then it may not make
sense to administer the vaccine broadly as a preventive
measure," Anderson said in a research note before the EMA
In the United States, Novartis is still working with
authorities to design U.S.-specific Phase III clinical trials.